Questions are being raised over whether India’s drug regulator, Central Drugs Standard Control Organization, properly vetted certain COVID19 vaccines.
A COVID-19 vaccine named Corbevax looked like a triumph for India’s burgeoning drug industry. Because its U.S. developers hadn’t claimed a patent on it, an Indian manufacturer named Biological E was able to sell the two-dose protein-based vaccine to the government at the extraordinarily low price of 145 rupees per dose. In March, the country began to give the shots to 12- to 14-year-olds, a group for which India did not yet have a licensed COVID-19 vaccine.
CDSCO has a decent reputation: Based on an extensive assessment, WHO concluded in 2017 that it was a “functional” drug regulator, a distinctionBut the pandemic has been challenging for CDSCO, says Gagandeep Kang, a public health microbiologist at Christian Medical College, Vellore.
In March, CDSCO’s reputation took another hit when a WHO inspection of the Covaxin manufacturing facility in Hyderabad, whose nature WHO has not disclosed. WHO recommended that member countries stop using the vaccine, and Bharat voluntarily halted exports. But the company has downplayed the problems and says it will keep selling Covaxin in India. CDSCO did not respond to questions from about the problems or why it failed to spot them.
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